Recruiting
Phase 2

Observational Study

Sponsor:

University of Southern California

Code:

NCT06345859

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 27

Healthy Volunteers: Accepted

Interventions

Heart rate variability biofeedback

Study Details

Brief summary:

Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.

Conditions

Major Depressive Disorder

Study ID

NCT06345859

Start date

Mar 22, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 27

Healthy Volunteers: Accepted

Inclusion Criteria for Participants with Remitted Depression:

1. Age 18-27.
2. Meeting criteria for lifetime major depressive disorder.
3. Currently meeting criteria for full remission (absence of clinically significant symptoms) for at least eight weeks, and having a Hamilton Depression Rating Scale score of less than or equal to 7.

Inclusion Criteria for Healthy Volunteer Participants:

1. Age 18-27.
2. No lifetime history of any psychiatric disorder.
3. No first-degree relatives with a mood disorder.

Exclusion Criteria (same for all participants):

1. Change in psychotropic medication use within the last 30 days
2. Autism spectrum disorder
3. Current eating disorder
4. Intellectual disability
5. Substance use disorder within the past 6 months
6. Contraindications for magnetic resonance imaging or electrocardiogram assessment (e.g., presence of metal in body, claustrophobia, cardiac device, pregnancy).

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Osc+

Osc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations.

active comparator: Osc-

Osc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score.

Interventions

Heart rate variability biofeedback

This is a Phase 2 parallel intervention design with random assignment. We will randomly assign participants to one of two biofeedback conditions. Both conditions involve completing breathing exercises at home, 30 minutes per day for 10 days, while receiving continuous feedback about parasympathetic activity from the computer.

Primary outcome measure

  • Physiological regulation success [ Time Frame: The two 10-day ambulatory assessment periods. ]
  • Average level of heart rate variability [ Time Frame: The two 10-day ambulatory assessment periods. ]

Central Contacts and Locations

Central contacts

Umiemah Farrukh

2137404503carlab@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Umiemah Farrukh

2137404503carlab@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-05-04.